Larotaxel Compared To Continuous Administration of 5-FU in Advanced Pancreatic Cancer Patients Previously Treated With A Gemcitabine-Containing Regimen

Pancreatic Neoplasms Clinical Trial

— PAPRIKA  

Official title:

A Randomized, Open Label Multi-Center Study Of Single Agent Larotaxel (XRP9881) Compared To Continuous Administration of 5-FU For The Treatment Of Patients With Advanced Pancreatic Cancer Previously Treated With A Gemcitabine-Containing Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00417209
• Other study ID #: EFC6596
• Secondary ID: EUDRACT: 2006-00
• Status: Completed
• Phase: Phase 3
• First received: December 28, 2006
• Last updated: August 9, 2011
• Start date: December 2006
• Est. completion date: November 2009

Study information

• Verified date: August 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy and the safety Larotaxel administered as single agent every 3 weeks to continuous administration of 5-FU every 3 weeks, in patients with advanced pancreatic cancer (non operable in a curative intent, locally recurrent or metastatic) previously treated with gemcitabine based therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 408
• Est. completion date: November 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Advanced (non operable in a curative intent, locally recurrent or metastatic disease) Cytologically or histologically proven epithelial cancer (adenocarcinoma) of the exocrine pancreas.

• Patient must be previously treated with a systemic gemcitabine based regimen

• Adequate bone marrow, kidney and liver functions

Exclusion Criteria:

• ECOG performance status (PS) of 2-3-4.

• Prior locoregional radiotherapy for pancreatic cancer.

• Symptomatic brain metastases or leptomeningeal disease.

• Any serious intercurrent infections, uncontrolled cardiac or gastro-intestinal diseases.

• Other concurrent malignancy

• Other protocol-defined exclusion/inclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

Drug:
• larotaxel (XRP9881)
IV infusion
• 5-Fluorouracil
administered either by IV or oral route

Locations

Country	Name	City	State
Belgium	Sanofi-Aventis Administrative Office	Diegem
Brazil	Sanofi-Aventis Administrative Office	Sao Paulo
Canada	Sanofi-Aventis Administrative Office	Laval, Quebec
Chile	Sanofi-Aventis Administrative Office	Santiago de Chile
Colombia	Sanofi-Aventis Administrative Office	Santafe de Bogota
Czech Republic	Sanofi-Aventis Administrative Office	Praha
Finland	Sanofi-Aventis Administrative Office	Helsinki
Germany	Sanofi-Aventis Administrative Office	Berlin
Hungary	Sanofi-Aventis Administrative Office	Budapest
India	Sanofi-Aventis Administrative Office	Mumbai
Italy	Sanofi-Aventis Administrative Office	Milan
Mexico	Sanofi-Aventis Administrative Office	Mexico
Norway	Sanofi-Aventis Administrative Office	Lysaker
Peru	Sanofi-Aventis Administrative Office	Lima
Poland	Sanofi-Aventis Administrative Office	Warszawa
Russian Federation	Sanofi-Aventis Administrative Office	Moscow
Slovakia	Sanofi-Aventis Administrative Office	Brastislava
Spain	Sanofi-Aventis Administrative Office	Madrid
Turkey	Sanofi-Aventis Administrative Office	Istanbul
United Kingdom	Sanofi-Aventis Administrative Office	Guildford, Surrey
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Canada,  Chile,  Colombia,  Czech Republic,  Finland,  Germany,  Hungary,  India,  Italy,  Mexico,  Norway,  Peru,  Poland,  Russian Federation,  Slovakia,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival (OS) defined as the time interval from the date of randomization to the date of death due to any cause		study period	No
Secondary	Progression free survival (PFS); Overall Response Rate (proportion of patients with confirmed RECIST-defined complete response (CR) or partial response (PR); clinical benefit based on the measurement of tumor related symptoms;		study period	No